FDA Regulatory
Consulting

Leaders in FDA Regulatory Solutions

Why FDA Strategy Matters

FDA Strategy Should Lead Your Development — Not Catch Up to It.

Most regulatory delays trace back to decisions made before FDA was ever in the room: a protocol amendment that closes off a future label claim, a CMC change that triggers comparability that nobody planned for, an indication that a Type B meeting could have reshaped. We embed senior consultants who have lived inside FDA processes — translating evolving guidance into a strategy your scientists, your investors, and the agency can all defend.

Ready to align your program with FDA expectations before they become FDA findings?

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Capabilities

Six Disciplines. One Embedded Leader.

Our FDA practice covers the full arc of regulatory decision-making — from the strategy memo that guides your first investor pitch to the post-approval supplement that protects your franchise.

Regulatory Strategy

Integrated development plans, target product profiles, accelerated pathway analysis, and independent gap reviews.
FDA Meeting Strategy

Question development, briefing book authoring, meeting rehearsal, and on-the-day support for Type A–D and Advisory Committee meetings.
FDA Submissions

IND, NDA, BLA, ANDA, 510(k), De Novo, PMA, IDE, Q-submissions, and lifecycle filings — authored, reviewed, or fully managed.
Nonclinical Development

IND-enabling study design, GLP toxicology oversight, DMPK strategy, and CRO selection across small molecule, biologic, and advanced therapy modalities.
Clinical Development

Protocol review, endpoint and comparator selection, statistical plan input, and clinical-regulatory issue resolution from Phase 1 to pivotal.
Regulatory CMC

Comparability protocols, process validation, specifications, manufacturing change control, and combination product CMC strategy.
Regulatory Strategy & Gap Analysis

The Plan That Decides Everything Downstream.

Every program lives or dies by the strategy behind it. We build integrated regulatory plans that map the shortest credible path from your current data package to approval — accounting for indication, modality, available accelerated pathways, and the realistic budget and timeline. When the strategy is already in place, we run an independent gap analysis to surface what FDA will challenge before they do.

Included Capabilities

  • Target Product Profile (TPP) development
  • Indication selection and label strategy
  • Accelerated pathway analysis (Breakthrough, Fast Track, Orphan, RMAT, Priority Review)
  • Pediatric and post-marketing requirement planning
  • Lifecycle management and label expansion strategy
  • Independent regulatory gap analysis
  • Investor- and board-ready regulatory diligence support
FDA Meeting Strategy

One Meeting Can Reshape a Program for Years.

FDA meetings are short, infrequent, and high-leverage. A single Type B meeting can re-shape your development program — or quietly close off the regulatory pathway you assumed you had. We prepare your team end to end: formulating the questions, authoring the briefing book, anticipating reviewer pushback, rehearsing your presenters, and supporting the room on the day. You walk in with a position. You walk out with alignment.

Meeting Types Supported

  • Pre-IND meetings (Type B)
  • End-of-Phase 1 and End-of-Phase 2
  • Pre-NDA and Pre-BLA
  • Type A, B, C, and D meetings
  • Advisory Committee preparation and rehearsal
  • Breakthrough Therapy and INTERACT meetings
  • Pre-submission meetings for medical devices (Q-Sub)
FDA Submissions

Every Document Becomes Part of Your Permanent Record.

From the first IND to a label expansion ten years later, every submission you file lives forever in your product's regulatory history. We author and review the documents FDA reviewers will actually read — quality, nonclinical, clinical, statistical, and labeling — and pressure-test them against current reviewer expectations before they leave your hands. Authored well, a submission anticipates the deficiency letter. Authored poorly, it generates one.

Submission Types Covered

  • IND, NDA, BLA, ANDA, and supplements
  • 510(k), De Novo, PMA, and IDE
  • Q-Submissions and pre-submissions
  • Orphan Drug Designation (ODD) requests
  • Pediatric Study Plans and post-marketing requirements
  • Annual reports and lifecycle filings
  • eCTD publishing coordination and dispatch

Filing a submission this quarter? Let a senior reviewer pressure-test it first.

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Nonclinical Development

What You Test Before First-in-Human Echoes for a Decade.

Nonclinical decisions made in IND-enabling studies echo through every later phase. We help sponsors design a fit-for-purpose pharmacology, pharmacokinetics, and toxicology program — calibrated to your modality, route, indication, and likely first-in-human design — so you neither under-test (and face an IND hold) nor burn capital on studies FDA never asked for.

Included Capabilities

  • IND-enabling study package design
  • GLP toxicology program oversight
  • DMPK and ADME strategy
  • Safety pharmacology program design
  • Juvenile and reproductive toxicology for pediatric indications
  • CRO selection, oversight, and report review
  • Modality-specific guidance: small molecule, biologic, cell & gene, peptide, oligonucleotide
Clinical Development

Clinical Strategy Is Regulatory Strategy.

The design of your pivotal trial — endpoints, populations, comparators, statistical plan — determines whether your data package will support approval or trigger a refusal-to-file. We work alongside your clinical and biostatistics teams to make sure trial decisions made today won't become NDA issues two years from now. When clinical-regulatory conflicts arise mid-program, we help resolve them without restarting the trial.

Included Capabilities

  • Protocol design and amendment review
  • Endpoint and comparator selection
  • Statistical analysis plan input
  • DMC / DSMB charter and strategy
  • Real-world evidence integration
  • Clinical-regulatory issue resolution mid-program
  • Integrated summaries of safety and effectiveness (ISS / ISE)
Regulatory CMC

Most Late-Stage Delays Actually Start in CMC.

Comparability across manufacturing changes, validation strategy for novel modalities, specifications that FDA will and won't accept — these are the questions we help sponsors answer from candidate selection through post-approval lifecycle management. CMC is rarely what teams want to focus on. It's almost always what trips them up.

Included Capabilities

  • CMC strategy from preclinical through commercial
  • Comparability protocols across manufacturing changes
  • Process validation (Stage 1 design through Stage 3 monitoring)
  • Specifications and stability program strategy
  • Manufacturing site change management and supplements
  • Combination product CMC and 21 CFR Part 4 alignment
  • Analytical method validation and transfer
Additional Services

Operational and Specialty Support.

Beyond core regulatory strategy, we support two adjacent functions where senior expertise tends to be hardest to recruit on a full-time basis.

Regulatory Operations

Submission Quality Is Operational Discipline.

Submission outcomes are increasingly a function of the workflow behind them. We support sponsors with eCTD publishing, dossier lifecycle management, ESG (Electronic Submissions Gateway) compliance, and the operational infrastructure required to file consistently as your pipeline scales from one program to many.

Included Capabilities

  • eCTD publishing and validation
  • Dossier lifecycle management
  • ESG account setup and ongoing compliance
  • Submission tracking and metrics
  • Regulatory information management (RIM) selection
  • SOP development for regulatory operations
Medical Devices & Combination Products

The Messiest Intersection of FDA Regulation.

Combination products and software-enabled devices sit at the most ambiguous edge of FDA regulation. We help sponsors navigate primary mode of action determinations, Center jurisdiction, 21 CFR Part 4 expectations, predicate selection, and the IDE / 510(k) / De Novo / PMA choice — without losing time and capital to the wrong submission type.

Included Capabilities

  • Primary mode of action (PMOA) determination
  • Request for Designation (RFD) preparation
  • Predicate device selection and substantial equivalence strategy
  • De Novo classification requests
  • 21 CFR Part 4 combination product compliance
  • Software as a Medical Device (SaMD) classification
  • Cybersecurity and pre-market submission requirements
Who You're Working With

FDA Experience That Came From Inside the Agency.

Our fractional regulatory leaders include former FDA reviewers, industry chief regulatory officers, and senior consultants with decades of submission and meeting experience across every major therapeutic area. You aren't being staffed with junior consultants under a partner's name — you get the senior practitioner on every call.

Former Agency Experience

Practitioners who have reviewed submissions, chaired meetings, and issued decisions from inside FDA — and who know how reviewers actually read your dossier.

Senior-Only Engagement Model

The lead consultant on your engagement is the one doing the work. We don't bait-and-switch with junior staff after the contract is signed.

Cross-Functional Fluency

Our leaders span regulatory, clinical, nonclinical, CMC, and quality — because real-world regulatory problems rarely respect functional boundaries.

Modality and Therapeutic Breadth

Small molecule, biologic, cell & gene, medical device, diagnostic, and digital health — across oncology, rare disease, neuroscience, immunology, and beyond.

Work With Us

Ready to Move Your FDA Program Forward?

Tell us where you are in the development cycle and what you need. We'll match you with a senior regulatory lead and respond within one business day. All inquiries are strictly confidential.

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Insights & News

Thought Leadership on FDA Strategy.

Our team's perspectives on FDA guidance, submission strategy, and the operational realities of regulatory work — coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

FDA Meeting Briefing Book Playbook

What to include — and what to leave out — in a Type B briefing package.

Coming Soon

Accelerated Pathway Decision Framework

Choosing between Breakthrough, Fast Track, Orphan, and RMAT designations.

Coming Soon

CMC Comparability After Manufacturing Changes

What FDA reviewers actually want to see in a comparability protocol.